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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mobile
510(k) Number K240009
Device Name iQFlex Pro
Applicant
First Source, Inc.
3495 Winton Place, Bldg. E, Suite 1
Rochester,  NY  14623
Applicant Contact Woo Sung Park
Correspondent
First Source, Inc.
3495 Winton Place, Bldg. E, Suite 1
Rochester,  NY  14623
Correspondent Contact Daniel Kamm
Regulation Number892.1720
Classification Product Code
IZL  
Date Received01/02/2024
Decision Date 07/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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